The Role
Lead site QA for GMP/GDP manufacturing and distribution, overseeing quality operations, deviations, CAPAs, inspections, secondary packaging, warehouse controls, and a QA team. Drive QMS improvements, regulatory compliance, risk-based decisions, and cross-functional stakeholder engagement to protect patient safety and product quality.
Summary Generated by Built In
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The Site US Senior GMDP Quality Assurance Manager will provide senior leadership and accountability for the site quality assurance function supporting distribution and manufacturing activities, including secondary packaging and labelling. The role will oversee day-to-day site quality operations, ensure continued compliance with regulatory Good Manufacturing and Distribution Practice standards, and drive effective, risk-based decisions and operational improvements. The Senior GMDP Quality Assurance Manager will act as a senior quality subject matter expert and escalation point, partnering with supply chain and logistics, project management and other departments to enable compliant delivery of client solutions across Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.
The Ideal Candidate:
- Attention to detail
- Proactive and self-motivated
- Calm and logical under pressure
- Strong leadership mindset
What You'll Do:
- Accountable for day-to-day site quality operations, ensuring critical quality records and activities are completed on time while protecting patient safety and product quality.
- Lead the effective operation and continual improvement of the site Quality Management System, ensuring compliance with GDP/GMP, procedural standards, and applicable regulatory requirements.
- Own and report site quality performance indicators, identify trends and systemic risks, and drive timely, data-led corrective and improvement actions.
- Provide hands-on quality oversight of warehouse distribution, manufacturing, secondary packaging, and related supply chain/logistics activities.
- Complete or oversee risk assessments, support compliant decision-making, and act as the escalation point for site-specific quality issues or GxP-critical events.
- Ensure timely and effective completion of quality records, including deviations, complaints, CAPAs, change controls, customer verification, investigations, and root cause analyses.
- Oversee secondary packaging quality activities, including packaging strategy, specification review/approval, executed batch record review, QA oversight, and product disposition.
- Complete critical warehouse reviews as Responsible Person, Deputy Responsible Person, or Equivalent Delegate, including maintenance, pest control, cleaning, calibration, and related records.
- Partner with EU/UK Qualified Persons on communications, GMP queries, batch certification activities, and associated processes where applicable.
- Lead site inspection readiness, self-inspections, client audits, regulatory inspections, audit responses, CAPAs, and sustained remediation of findings.
- Lead, coach, develop, and line manage the QA site operations team, including resourcing, capability, succession planning, training, performance feedback, and technical development.
- Provide quality leadership for client communications, Quality Technical Agreements, recalls, continuous improvement projects, business initiatives, and a strong quality culture across the organization.
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 7+ years of relevant pharmaceutical or life sciences quality assurance experience, including substantial responsibility within both GMP and GDP operations
- Proven senior leadership and people management capability, with experience setting direction, influencing cross-functional stakeholders and making sound quality decisions in complex or time-critical situations
- Experience with UK, FDA, and EU regulations related to manufacturing and distribution operations
- Extensive applied knowledge of GMP and GDP, including data integrity, label control, secondary packaging, risk-based quality management, deviations, change control, supplier/customer management, and QMS processes
- Experience reviewing and approving deviations related to secondary packaging activities
- Strong ability to make independent, risk-based decisions while balancing business needs and quality requirements
- Highly organized and able to manage multiple priorities to strict deadlines with accuracy, adaptability, and sound judgment under pressure
- Strong communication and stakeholder management skills, with the ability to explain complex quality issues to quality and non-quality personnel
- Ability to support cross-functional projects, investigations, root cause analysis, process improvements, QMS/business process development, and proactive escalation of quality, business, or client-related risks
- IT literate, including Microsoft Outlook, Word, and Excel
- Willing to be on-site 5 days a week, if required
Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
What We Offer:
Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any stage of recruitment
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
#LI-Fulltime #LI-hybrid
Skills Required
- Bachelor's degree or higher
- Degree in pharmaceutical, life sciences, or engineering (preferred)
- 7+ years pharmaceutical or life sciences quality assurance experience including GMP and GDP operations
- Proven senior leadership and people management experience
- Experience with UK, FDA, and EU regulations for manufacturing and distribution
- Extensive applied knowledge of GMP and GDP (data integrity, label control, secondary packaging, risk-based QMS, deviations, change control)
- Experience reviewing and approving deviations related to secondary packaging activities
- Hands-on quality oversight of warehouse distribution, manufacturing, secondary packaging, and supply chain/logistics
- Experience leading inspection readiness, audits, regulatory inspections, CAPAs and remediation
- Strong communication and stakeholder management skills
- Ability to make independent, risk-based decisions balancing business needs and quality requirements
- IT literate, including Microsoft Outlook, Word, and Excel
- Willingness to be on-site 5 days a week, if required
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The Company
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
